AliveDx is recruiting for a Department Leader, Product Development to join the Product Development team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.
Job Purpose: To lead, manage and provide scientific direction across all aspects of product/process development projects in relation to Alba products. All in accordance with operational objectives, statutory and regulatory requirements, and the principles of GMP in support of products which are marketed worldwide. This will often involve interaction with external parties. Accountable for delivery of projects to timelines and quality expectations.
YOUR MISSION
Your main responsibilities will include:
* Manage the product development activities of Alba products to ensure customers’ needs, strategic objectives and performance targets are met.
* Provide expertise in assay development, product validation, product requirement definitions and licensure.
* Deputise for the Head of Department in product development areas, to drive scientific solutions as required.
* Own/manage custom and complex projects, working with Project Management, troubleshooting and technical/scientific issues to ensure continuous improvement/development of products and processes.
* Chairs technical reviews and provides departmental training. Leads scientific workshops to address cross-departmental assay issues, ensuring flawless transition from feasibility to development through to validation and then into commercial approval.
* Assist the department in general organisation and administration of laboratory facilities, such as documentation and audits to ensure departmental compliance with health and safety, GMP/GLP standards.
* Lead and troubleshoot complex issues regarding reagent quality and assay robustness, offering support to the wider Technical/ Product Support groups as necessary.
* Undertake supervision, training, and appraisals of junior staff to ensure that staff with appropriate skills and knowledge of laboratory organisation and procedures are available to meet the requirements of the department's planned programmes of work.
YOUR COMPETENCIES
* Significant Subject Matter knowledge and demonstrable seniority in the relevant field.
* Experience in blood group serology/disease screening is essential plus laboratory experience in a GMP environment.
* Experience (or confidence if first time manager) in managing staff and directing the work of others.
* Proven leader of teams, motivating character and ensuring priorities are clear.
* Knowledge/Experience of instrumentation/automation used in the field of blood transfusion diagnostics.
* Ability to act as a scientific and collaborative role model.
WHAT WE OFFER
* A highly dynamic and growing environment.
* An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
* A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.
Interested ? We look forward to receiving your application.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.
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